TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor
This research study, called TiNivo-2, is looking at a type of kidney cancer called renal cell carcinoma. It's for patients whose cancer has progressed after one or two previous treatments, with at least one of those treatments being an 'immune checkpoint inhibitor' like nivolumab. The study is comparing two different treatment approaches: one group will receive a drug called tivozanib along with another drug called nivolumab (which you might know as OPDIVO); the other group will receive tivozanib on its own. Doctors want to find out if the combination treatment can better control the cancer and help people live longer without their cancer getting worse, compared to tivozanib alone. They will also look at how long people live overall, how many people respond to the treatment, and any side effects.
At a glance
What is this study about?
This study, called TiNivo-2, is an important research project for people living with kidney cancer, specifically renal cell carcinoma. It focuses on patients whose cancer has started to grow or has come back after they've already received one or two different treatments. At least one of these previous treatments must have been a type of drug that works by boosting the body's own immune system to fight cancer.
The main aim of this study is to compare two treatment plans. One plan involves taking a drug called tivozanib together with another drug called nivolumab. Nivolumab is also known by its brand name, OPDIVO, and it's a well-known type of immunotherapy. The other plan involves taking tivozanib on its own. By comparing these two approaches, doctors hope to learn if the combination treatment is more effective at stopping the cancer from growing or spreading.
Throughout the study, doctors will carefully monitor how long patients live without their cancer getting worse, how long they live overall, and how many people respond positively to the treatment. They will also keep a close eye on any side effects to understand how safe and tolerable each treatment plan is. This type of study is called a 'Phase 3' trial, which means it's one of the final steps before a new treatment might be approved for wider use.
Key takeaways
- This study is for adults with kidney cancer that has progressed after previous treatments.
- It compares a new combination of two drugs (tivozanib plus nivolumab) against tivozanib alone.
- The main goal is to see if the combination helps control the cancer for longer.
- Participants will be randomly assigned to one of the two treatment groups.
- Regular hospital visits, tests, and scans will be part of the study.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women can take part. To be considered, you must have kidney cancer that has continued to grow or has returned after you've already had one or two different treatments.
Crucially, one of your previous treatments must have been a type of immunotherapy that helps your body's immune system fight cancer. If you meet these general criteria, the study doctors will do more detailed checks to ensure it's the right study for you, and that it's safe for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with renal cell carcinoma (kidney cancer)?
- Has your cancer grown or come back after one or two previous treatments?
- Did at least one of your previous treatments include an immunotherapy drug?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin – neither you nor your doctor can choose which group you join. One group will receive two medications (tivozanib and nivolumab), and the other group will receive tivozanib on its own. You will receive these treatments regularly as part of the study plan.
Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI scans) to see how your cancer is responding and to monitor for any side effects. The medications used in the study will be provided to you. The exact number of visits and the total length of time you'll be involved can vary depending on how your cancer responds to the treatment.
Potential risks and benefits
Locations (8)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedBelgium
Common questions
What is renal cell carcinoma?
It's the most common type of kidney cancer that starts in the small tubes in your kidney.
What does 'progressed' mean in this study?
It means your cancer has started to grow or spread after receiving previous treatments.
What is an 'immune checkpoint inhibitor'?
It's a type of drug that helps your body's own immune system recognise and fight cancer cells more effectively.
What are tivozanib and nivolumab?
These are both types of anti-cancer drugs being tested. Nivolumab is also known as OPDIVO.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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